The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis
- 24 August 2013
- journal article
- review article
- Published by Springer Science and Business Media LLC in Breast Cancer Research and Treatment
- Vol. 141 (1), 13-22
- https://doi.org/10.1007/s10549-013-2666-z
Abstract
The impact of the Oncotype Dx (ODX) breast cancer assay on adjuvant chemotherapy (ACT) treatment decisions has been evaluated in many previous studies. However, it can be difficult to interpret the collective findings, which were conducted in diverse settings with limited sample sizes. We conducted a systematic review and meta-analysis to synthesize the results and provide insights about ODX utility. Studies, identified from PubMed, Embase, ASCO, and SABCS, were included if patients had ER+, node −, early-stage breast cancer, reported use of ODX to inform actual ACT decisions. Information was summarized and pooled according to: (1) distribution of ODX recurrence scores (RS), (2) impact of ODX on ACT recommendations, (3) impact of ODX on ACT use, and (4) proportion of patients following the treatment suggested by the ODX RS. A total of 23 studies met inclusion criteria. The distribution of RS categories was 48.8 % low, 39.0 % intermediate, and 12.2 % high (21 studies, 4,156 patients). ODX changed the clinical-pathological ACT recommendation in 33.4 % of patients (8 studies, 1,437 patients). In patients receiving ODX, receipt of ACT were: 28.2 % overall, 5.8 % low, 37.4 % intermediate, and 83.4 % high. High RS patients were significantly more likely to follow the treatment suggested by ODX versus low RS patients RR: 1.07 (1.01–1.14). The pooled results are consistent with most individual studies to date. The increased proportion of intermediate scores relative to original estimates may have implications for the clinical utility and cost impacts of testing. In addition, low versus high RS patients were significantly more likely to follow the ODX results, suggesting a tendency toward less aggressive treatment, despite a high ODX RS. Finally, there was a lack of studies on the impact of ODX on ACT use versus standard approaches, suggesting that additional studies are warranted.Keywords
This publication has 49 references indexed in Scilit:
- A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studiesThe Lancet, 2012
- Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100 000 women in 123 randomised trialsThe Lancet, 2012
- Validation Study of a Quantitative Multigene Reverse Transcriptase–Polymerase Chain Reaction Assay for Assessment of Recurrence Risk in Patients With Stage II Colon CancerJournal of Clinical Oncology, 2011
- Association Between the 21-Gene Recurrence Score Assay and Risk of Locoregional Recurrence in Node-Negative, Estrogen Receptor–Positive Breast Cancer: Results From NSABP B-14 and NSABP B-20Journal of Clinical Oncology, 2010
- Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer?Genetics in Medicine, 2009
- Comparison of gene expression profiles predicting progression in breast cancer patients treated with tamoxifenBreast Cancer Research and Treatment, 2008
- American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast CancerJournal of Clinical Oncology, 2007
- Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast CancerJournal of Oncology Practice, 2007
- Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trialsThe Lancet, 2005
- A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast CancerThe New England Journal of Medicine, 2004